FDA Inspection
Cascadia Manufacturing IncCascadia Manufacturing Inc – FDA Inspection, Sep 7, 2011
Record Details
This FDA Inspection record concerns Cascadia Manufacturing Inc, with an inspection on September 7, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cascadia Manufacturing Inc
- Inspection Date
- September 7, 2011
- Product Type
- Drugs
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ID · 7c57884e-7d1f-42c3-8e74-30641b8da8f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 743164
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.84(d)(6)Objectionable microbiological contamination
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.42(c)Defined areas of adequate size for operations
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Other FDA inspections of Cascadia Manufacturing Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2016 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| July 12, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 16, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 14, 2009 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for Cascadia Manufacturing Inc
- FDA Inspection 985991 - 2016-03-01
- FDA Inspection 787973 - 2012-07-12
- FDA Inspection 696483 - 2010-11-16
- FDA Inspection 609014 - 2009-08-14
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